Device Survival Probability

SECURA_DR_SURV

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1 yr

2 yr

3 yr

4 yr

5 yr

6 yr

7 yr

8 yr

at 101.0 mo

%

100.0

99.9

99.9

99.8

99.8

99.7

99.7

99.6

99.6

%

99.6

99.4

99.1

98.2

95.4

88.3

72.0

41.4

21.3

#

45387

42535

39942

37062

33183

26052

16120

3704

517

Including Normal Battery Depletion – This curve includes devices that have reached at least 80% of expected longevity. This curve is most representative of clinical performance and how long the device will last.

Malfunctions (USA)

Malfunctions (WW)

Therapy Function Not Compromised

23

Battery

4

Electrical Component

9

Possible Early Battery Depletion

10

Therapy Function Compromised

5

Electrical Component

4

Software/Firmware

1

EOS Indication

The Prolonged Service Period (PSP) is the time between the RRT and EOS. The PSP is defined as 3 months assuming the following conditions: 100% DDD pacing at 60 min-1, 2.5 V atrial and RV pacing amplitude; 0.4 ms pulse width; 600 &#937; pacing load; and 6 full-energy charges. The EOS may be indicated before the end of 3 months if the device exceeds these conditions.

Recommended Replacement (RRT)

Battery voltage less than or equal to 2.63V on 3 consecutive daily automatic measurements.